Clinical TrialID 7279

Enoxolone in Major Depression - Biomarker-outcome Relationship

NCT05570110

Unipolar Depression

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Record Fields

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Clinical Trial Id
7279
Evidence Id
7279
Core Evidence Id
7279
Source Clinical Trial Id
7270
Herb2 Clinical Trial Id
HBCT007270
Nct Id
NCT05570110
Title
Enoxolone in Major Depression - Biomarker-outcome Relationship
Status
Recruiting
Phase
Phase 1|Phase 2
Study Result
No
Study Condition
Unipolar Depression
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Intervention
DRUG: Enoxolone
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Diagnostic
Gender
All
Age
Adult, Older_Adult
Enrollment
60
Outcome Measure
Systolic blood pressure, Systolic blood pressure at rest at baseline as a predictor for treatment differentiation, Baseline, as predictor for differentiation of treatment groups clinical response|Urine aldosterone/cortisol ratio, Ratio of nocturnal urine aldosterone concentration/urine cortisol concentration, Baseline, as predictor for differentiation of treatment groups clinical resposne|Depression rating, Hamilton depression rating scale (HAMD) - 17 items; higher is worse, change from baseline to week 4, with systolic blood pressure as covariate|Depression self rating, Patient health questionnaire for depression (PHQ-9), higher is worse, change from baseline to week 4, with systolic blood pressure as covariate
Sponsor Collaborator
Philipps University Marburg Medical Center|Slovak Academy of Sciences
Funded By
OTHER
Location
Clinic for Psychiatry and Psychotherapy, Marburg, Hessen, 35039, Germany
Other Id
MNS_02.1
Start Date
2022-09-23
Primary Completion Date
2025-03
Completion Date
2025-03
First Posted
2022-10-06
Results First Posted
Last Update Posted
2024-04-09
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05570110
Title Cn
Title En
Enoxolone in Major Depression - Biomarker-outcome Relationship
Bilingual Status
semi_complete